1. The European legal framework for patentability and regulation of stem cells : focus on Germany, Spain and France Paul Van den Bulck Partner at Ulys Law Firm (Brussels-Paris) Lecturer at R. Schuman University (Strasbourg) www.ulys.net paul.vandenbulck@ulys.net 27 th November 2006

2. Structure  I. Introduction  II. European legal framework (A.) Directive 98/44/CE (B.) European Patent Convention  III. National legal framework in : (A.) Germany (B.) Spain (C.) France

3. I. Introduction

4.  At the European level, several bodies have addressed the issue of the patentability of human pluripotent embryonic stem cells and stem cell lines: –the European Commission (two 16c reports) –the European Commission Experts Group (preparation of the second 16c reports) –the European Group on Ethics –the European Patent Office (case law)

5.  At the national level ? 1. Legislation depends on the status of the embryo : - Spain and UK : ≠ between embryo and pre-embryo - Germany : the embryo is an entire person - France : status of the embryo not defined 2. National ethical comities Exception : Spain (no comity)

6. II. European legal framework

7.  Article 5 (1): “The human body, at the various stages of its formation and development, and the simple discovery of one of its elements... cannot constitute patentable inventions”. A. Directive 98/44/CE

8.  In application of article 5(1): –totipotent stem cells = unpatentable (since they are capable of developing into a human being) –embryos = unpatentable (common position of the EC Council of 26 Feb. 1998) –germ cells = unpatentable (recital 16)

9.  What about pluripotent stem cells? Complex situation  Article 5 (2): “An element isolated from the human body... including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.”

10.  Article 5 (2): – allows the patentability of human stem cells; – allows the patentability of human stem cell lines (if the invention is new, involves an inventive step and is susceptibel of industrial application)

11.  Article 6 of the Directive: 1.Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; 2....the following, in particular, shall be considered unpatentable: (...) (c) uses of human embryos for industrial or commercial purposes;...

12.  Article 6(2) is non exhaustive  Recital 42: article 6(2)c) does not affect inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it

13.  If one reads article 6(2)c) and recital 42 together then, according to the European Commission experts group: – Unpatentable: if the embryo is the source of the invention – patentable: if the embryo is the aim of the invention

14.  Article 6(2)c): does the unpatentability concerns: –an embryo as a whole?; or –every invention concerning stem cells? No consensus.  Importance of the interpretation of the concept of “embryo” in the national legislation of the Member States

15. B. European Patent Convention  Article 53(a): “Any invention, the publication or exploitation of which would be contrary to ordre public or morality, is specifically excluded from patentability”.

16.  Rules: –Rule 23(d): “European patents are not to be granted in respect of… inventions which concern…(c) uses of human embryos for industrial or commercial purposes” –Rule 23(e): “the human body, at the various stages of its development…”

17. ‘EDINBURGH PATENT’- case :  Patent granted in December 1999  patent for ‘animal transgenic stem cells’  EPO Opposition Proceedings (July 2002):  amendment to exclude human embryonic stem cells  adopted broad interpretation of Rule 23(d)(c) (6(2)c of directive)  does this mean that human embryonic stem cells are unpatentable ?  The decision of the Board of Appeal is awaited (end 2006)

18. III. National legal frameworks

19. A. Germany 1. Law on protection of the embryo (13 December 1990): - The embryo is an entire person - Banning of : - Creation/sampling of embryo’s with scientific purposes - Using of surpersurnumerary embryo’s obtained by procreation in vitro - Creation of lines of human embryonic stem cells - Any research on existing embryo’s - The law doesn’t say anything about importation of stem cells 2. Law of 25 April 2002 : Research allowed on imported stem cells: only for : a) scientific research for therapeutic purpose b) project of major importance

20. B. Spain 1. Difference between embryo and pre-embryo (like in UK) 2. Research allowed on the pre-embryo : 2.1. a) General conditions b) Supplementary conditions 2.2. Research allowed if it pursue specific purposes (like in UK) 3. Banning of the creation of embryonic stem cells with scientific purposes

21. 2.1. Conditions for the research a. General conditions 1) Written consent of the people concerned 2) No longer development in vitro than 14 days (pre-embryo) 3) The investigation has to be realized in a health centre + by legal scientific multidisciplinary teams + under control of the competent public authorities

22. b. Supplementary conditions 1) Research on pre-embryo viable in vitro - investigation with diagnostic/therapeutical/preventive purpose - no modification of the genetic patrimony (if no anomaly) 2) Research with other purpose than to maintain his survival only if : - on a non viable pre-embryo - ≠ possible on an animal model - research based on a project presented and allowed by the sanitary authorities - research realised in the authorised places

23. 2.2. Additional purposes (non viable) Pursuant to the art. 16 of the Spanish law, are authorized, :  The improvement of the techniques of medical assistance to the procreation and the complementary manipulations, the techniques of conservation and defrosting of embryo’s;  The research based on the origin of the human life and his initial steps, concerning the cell’s life and the cellular division or the death of the cell’s  The research concerning the process of differentiation, organisation of cell’s and development of the embryo  The research concerning the fertility and the infertility, masculine or feminine  The research concerning the structure of the gene and of the chromosomes, their localisation, identification, and their functioning  The research concerning the contraception  The research concerning certain phenomena (ex. immunity)  The research concerning the hormonal action  The research concerning the origin of the cancer  The research concerning the origin of the diseases and particularly serious diseases  Every other research which is considered as opportune to authorize, by regulation, or by the national multidisciplinary commission.

24. C. France 1.2004 : modification of the law (law 2004-800 on bioethics) 2. Principle : banning of any research on human embryo (L.2151-5) 3. 3.1. Some exceptions allowed 3.2. Framing of the allowed research 4. Banning of the creation of embryo’s with scientific purposes

25. 3.1. Research allowed (for a period of 5 years) 2 conditions : a) research likely to ensure therapeutic progress b) no alternative with comparable effectiveness

26. 3.2. Framing of the allowed research a) The embryo were conceived in the frame of a medical assistance to the procreation and is no more the subject of a parental project (supernumerary embryos) b) Written consent of the parents (of the survival parent of the couple) is requested c) Authorisation of the agency of the biomedicine is necessary

27. Paul Van den Bulck Partner at Ulys Law Firm (Brussels) Lecturer at R. Schuman University (Strasbourg) www.ulys.net paul.vandenbulck@ulys.net Questions & Answers